The European Union ought to renegotiate a 1 billion euro ($1.17 billion) contract it sealed final week with Gilead for a six-month supply of the COVID-19 drug, remdesivir, after it confirmed poor results in a big trial, specialists stated Friday.
In a blow to one of many few medicine getting used to deal with individuals with COVID-19, the Solidarity Trial carried out by the World Health Organization (WHO) confirmed Friday that remdesivir appeared to have little or no impact on mortality or size of hospital stays amongst sufferers with the respiratory illness.
The trial results had been disclosed per week after the EU’s government Commission introduced its largest contract to date with Gilead for the supply of 500,000 programs of the antiviral drug at a worth of two,070 euros ($2,425) per remedy, which Gilead stated was the usual for rich nations.
The Commission “wants to current the explanations behind the push to conclude the newest contract with Gilead and transfer to review it in gentle of the Solidarity Trial findings,” stated Yannis Natzis, who represents sufferers’ organizations on the board of the European Medicine Agency (EMA), the EU drug regulator.
The EU introduced on Oct. eight that it had signed the supply contract with the U.S. firm on behalf of its 27 member states and 10 associate international locations, together with Britain.
Gilead had recognized concerning the results of Solidarity since Oct. 6, the WHO stated, citing disclosure guidelines below the Solidarity Trial.
Gilead instructed Reuters it had obtained in late September a “closely redacted manuscript” from the WHO which contained completely different data from the ultimate doc printed on Friday.
“Time is of the essence”
The Commission’s determination was made after EU international locations warned of shortages of remdesivir of their hospitals amid a brand new surge of COVID-19 infections throughout Europe.
The contract doesn’t oblige international locations to purchase remdesivir, though it ties them to the agreed worth.
Gilead didn’t touch upon whether or not remdesivir’s worth for rich international locations may change after the WHO trial, and the corporate questioned its results.
“As time is of the essence – we’re in a state of affairs of a public well being emergency – we’ve to not solely make investments up-front in vaccine improvement but additionally in entry to therapeutics,” a spokesman for the European Commission stated.
He added the EMA would look into the Solidarity results and information out there from different research on COVID therapies “to see if any modifications are wanted to the best way these medicines are used.”
But the spokesman didn’t touch upon whether or not the EU was conscious of the Solidarity results earlier than it signed the contract with Gilead. He additionally didn’t reply to questions on whether or not the worth agreed with Gilead might be renegotiated.
“The EU ought to revisit the costs to be paid for remdesivir. Why pay 1 billion euros for a drug with no results on survival?” stated Andrew Hill, a senior visiting analysis fellow within the Department of Pharmacology on the University of Liverpool.
He stated generic variations of the drug manufactured in India had been offered at 200 euros per course.